Course topics include:

 

Overview of the days agenda

The criticality of calibration, A short history of calibration, Background of FDA

Requirements

21 CFR Part 820.72 (FDA – QSR), 21 CFR Part 820.25 (Training requirements),

21 CFR Part 58, 21 CFR Part 110, 21 CFR Part 211, and 21 CFR Part 606, ISO 9001, ISO 13485

A Quality Calibration Program

Calibration procedures – writing them, Formatting, Generic vs. specific types, using them, Document control

Updating and improving them, Training and availability, Validation vs. qualification

Calibration records, Specific requirements, The required items on a calibration form

Formatting, Filing, electronic and hard copy, How to make corrections to your records

Calibration labels, Calibration intervals, Calibration certificates, Traceability to the SI, TUR ≥ 4:1

Uncertainty budgets, Equipment 'end of life' requirements, The correct way to state NIST traceability

Complying with environmental requirements, Out of tolerance procedures

Examples of forms, Procedures and examples, Solutions for handling missing test equipment

Managing a Quality Calibration Program

Paperless Records using Adobe Acrobat Pro

If you have questions or need more information,
please send an email to: yokota-69@charter.net